[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pole Sante Oreliance, Polyclinique des Longues Allees\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100650498","comparison-between-opioid-sparing-anesthesia-guided-by-the-cardean-index-and-opioid-free-anesthesia-during-total-hip-arthroplasty-100650498",false,"NCT07747142","Comparison Between Opioid-sparing Anesthesia Guided by the CARDEAN® Index and Opioid-free Anesthesia During Total Hip Arthroplasty","Comparaison Entre anesthésie Avec épargne Morphinique guidée Par l'Index CARDEAN® et anesthésie Sans Morphinique au Cours Des Arthroplasties Totales de Hanche : étude randomisée","Inclusion Criteria:\n\n* Men and women\n* Patient aged at least 18 years\n* Signed informed consent\n* American Society of Anesthesiologists (ASA) Class 1 to 3\n* Scheduled total hip arthroplasty under general anesthesia (anterior or lateral approach) with local analgesic infiltration performed by the surgeon at the end of the procedure\n* Affiliated with or a beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* ASA Class 4 or 5\n* Emergency hip surgery\n* Indication for an anesthesia technique other than general anesthesia (patient preference, benefit-risk ratio, etc.)\n* Permanent cardiac arrhythmia or permanent cardiac pacing (invalid CARDEAN® index)\n* Resting bradycardia \\\u003C 50 bpm\n* Second- or third-degree atrioventricular block\n* Chronic opioid user\n* Refusal of consent\n* Patient unable to read, write, or understand French\n* Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP)\n* Adult patient under guardianship, curatorship, or judicial protection\n* Patient unable to personally provide consent as defined by Article L.1121-8 of the CSP, or an adult under legal protection\n* Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP","ALL","18 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"NA","The proposed study compares two anesthesia techniques; the hypothesis being tested is that titrating sufentanil based on the CARDEAN® index (titrated OSA) does not increase post-operative morphine consumption compared to opioid-free anesthesia (OFA). This CARDEAN®-guided titrated anesthesia approach could potentially allow for hospital discharge as early as 24 hours post-operatively and is compatible with ERAS protocols. The primary objective is to demonstrate that sufentanil administration guided by the CARDEAN® index (titrated OSA) does not increase postoperative morphine consumption compared to opioid-free anesthesia (OFA). This is a prospective, single-center, randomized, single-blind, non-inferiority study.\n\nTwo groups of 70 patients each (140 patients in total) are compared based on the type of intraoperative analgesia: titrated OSA (Arm 1) versus OFA (Arm 2).\n\nRandomization will be performed at a 1:1 ratio and stratified by surgical approach (anterior or lateral approach).",[26],"Total Hip Arthroplasty (THA)",[28,29,30,31],"Cardean","OSA","OFA","anesthesia","NOT_YET_RECRUITING","2026-07-30",{"date":35,"type":36},"2026-08-05","ACTUAL",{"date":38,"type":20},"2026-09-15",{"date":40,"type":20},"2027-10-01",{"name":42,"class":43},"Pole Sante Oreliance, Polyclinique des Longues Allees","OTHER",""]